The Effect of Hydration on the Prevention of CI-AKI in STEMI Patients Undergoing Primary PCI (Hyd… (NCT07761754) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Hydration on the Prevention of CI-AKI in STEMI Patients Undergoing Primary PCI (Hydro-AKI Trial)
384 participantsStarted 2026-08
Plain-language summary
The goal of this clinical trial is to determine whether a structured oral hydration regimen reduces the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). The main questions it aims to answer are:
Does a structured oral hydration regimen reduce the incidence of CI-AKI compared with standard care without a prescribed hydration regimen? Does oral hydration improve renal outcomes without increasing the risk of adverse events, such as heart failure or fluid overload, in patients undergoing PPCI?
Researchers will compare patients receiving a structured oral hydration regimen with patients receiving standard care without a prescribed hydration regimen to determine whether oral hydration decreases the incidence of CI-AKI and improves clinical outcomes.
Participants will:
Be randomly assigned to either the oral hydration group or the standard care group.
Undergo primary percutaneous coronary intervention according to institutional practice.
Receive the assigned hydration strategy after the procedure. Have serum creatinine measured at baseline and after contrast exposure to assess for CI-AKI.
Be monitored for adverse events, including fluid overload, heart failure, need for renal replacement therapy, length of hospital stay, and other relevant clinical outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion Criteria
All of the following must be present:
* Age ≥18 years at the time of randomization
* Clinical diagnosis of STEMI, confirmed by 12-lead ECG showing ≥30 minutes of ST-segment elevation ≥1 mm in ≥2 contiguous limb leads or ≥2 mm in ≥2 contiguous precordial leads, or new left bundle branch block with a clinical presentation consistent with acute myocardial infarction
* Decision to proceed with primary PCI as the reperfusion strategy, within 12 hours of symptom onset (or up to 24 hours if evidence of persistent ischaemia or haemodynamic instability)
* Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m², calculated by the CKD-EPI 2021 formula from the most recent available serum creatinine measurement prior to contrast exposure
* Ability to swallow and safely tolerate oral fluids, as assessed by the attending physician
* Oral informed consent obtained from the patient or a legally authorized representative (deferred consent protocol applies in emergencies per IRB approval)
Exclusion Criteria:
* \- Cardiogenic shock on presentation, defined as systolic blood pressure \<90 mmHg for \>30 minutes despite fluid resuscitation, or requirement for vasopressor or inotropic therapy to maintain SBP ≥90 mmHg, with evidence of end-organ hypoperfusion (Killip Class IV)
* Acute pulmonary oedema or Killip Class III with SpO₂ \<90% on room air, bilateral crepitations \>50% of lung fields, or chest X-ray showing pulmonary venous congestion requir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of contrast-induced acute kidney injury (CI-AKI)
Timeframe: Within 48 hours after primary percutaneous coronary intervention (PPCI)